DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SL...
FDA Device Recall #Z-2159-2019 — Class II — May 21, 2019
Recall Summary
| Recall Number | Z-2159-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 21, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | DRG Instruments GmbH |
| Location | Marburg, N/A |
| Product Type | Devices |
| Quantity | 38 kits |
Product Description
DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women. Fertility problems are not diagnosed on the outcome of Testosterone alone but accompanied by other diagnostic means
Reason for Recall
Salivary assay may observe a higher percentage of samples with 0 pg/ml testosterone or results which are too low. Saliva samples in the low measuring range of the kit(< 50 pg/ml) were assayed significantly lower
Distribution Pattern
Worldwide Distribution - US Nationwide CA, MI Foreign: Canada, Brazil, China, Poland
Lot / Code Information
Lot Numbers: 66K118, 66K019
Other Recalls from DRG Instruments GmbH
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2410-2019 | Class II | DRG Salivary Progesterone HS ELISA- IVD for the... | Jun 6, 2019 |
| Z-2836-2018 | Class II | Salivary Estradiol ELISA, REF SLV-4188 in vitro... | Jul 14, 2016 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.